The purpose of this study is to prospectively evaluate the efficacy of KARL STORZ curved fetoscope (11508AAK) and its straight version (11506AAK) for in-utero surgery
Outcome data will be compared to that of The Fetal Center's historical control group that underwent in-utero surgery without curved fetoscopes
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The type of fetoscope used in utero(either straight or curved or both ) will depend on the location of the placenta. The fetoscope will be used to cauterize abnormal blood vessels that cause twin-to-twin transfusion syndrome (TTTS)
The University of Texas health Science Center at Houston
Houston, Texas, United States
RECRUITINGGestational age at delivery in patients requiring percutaneous in-utero surgery
Time frame: at time of delivery (about 10 weeks after in utero surgery)
Number of successful procedures with completion of laser ablation of the abnormal vessels.
Time frame: within 24 hours of in utero surgery
Improved visualization as assessed by the Likert scale
This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree. This is not a validated scale and does not have an official title. The minimum value is strongly disagree and the maximum value is strongly agree. Higher scores mean better outcomes.
Time frame: within 24 hours of in utero surgery
Improved angle for laser visualization as assessed by the Likert scale
This is reported categorically as strongly disagree, disagree, neither agree not disagree, agree and strongly agree
Time frame: within 24 hours of in utero surgery
Improved ease of use of the new fetoscope as assessed by a questionnaire
This is a 4 item questionnaire and each is scored from 1(poor) to 5(excellent) for a maximum score of 20 higher score indicating better outcome
Time frame: within 24 hours of in utero surgery
Operative time in minutes
Time from from operative cannula insertion until it is removed
Time frame: end of surgery ( about 1 hour form start of surgery)
Number of fetuses alive prior to hospital discharge
Time frame: time of discharge (about 48 hours after surgery)
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Total number of maternal patients that present with short term morbidity
Short term morbidity includes but is not limited to, preterm labor, preterm premature rupture of membranes, or placental abruption
Time frame: from end of surgery to within 10 weeks after surgery
Total number of patients that have maternal and/or fetal perioperative complications
Time frame: from end of surgery to within 10 weeks after surgery
The number of participants that develop twin-anemia-polycythemia sequence (TAPS)
Time frame: from end of surgery to within 10 weeks after surgery
Total number of live births
Time frame: from time of in utero surgery till delivery (about 10 weeks after surgery)
Total number of short-term morbidities
Short-term morbidities include, but are not limited to, premature delivery (\<37 weeks), the need for extracorporeal membrane oxygenation (ECMO), neurological abnormalities found by MRI or ultrasound, gastrointestinal problems, oxygen support, infection and other problems associated with prematurity, including but not limited to, necrotizing enterocolitis, bronchopulmonary dysplasia, respiratory distress syndrome, and neonatal sepsis.
Time frame: from time of in utero surgery till delivery (about 10 weeks after surgery)